Reflecting on 25 Years of PR/HACCP – the Policy and Laboratories
Jack Connolly, Digital and Executive Communications Staff
FSIS Microbiologist Daryvone “Diana” Ngonhkeo performs shiga-toxin producing E. coli (STEC) testing on raw beef product samples at the FSIS Eastern Laboratory in Athens, Ga. Photo by Leo Gude, OPHS.
This year marks the 25th anniversary of FSIS’ landmark final rule, “Pathogen Reduction/Hazard Analysis and Critical Control Point (PR/HACCP),” which advanced science-based regulatory policies that successfully modernized and enhanced food safety inspection in the United States. Before the finalization of the PR/HACCP final rule, FSIS inspection program personnel (IPP) relied heavily on sight, smell and touch in their work inspecting meat and poultry. In the 1990s, it was recognized that depending so much on this type of inspection was not enough to ensure safe meat and poultry products. In 1993, over 700 became ill and 4 died in an outbreak of E. coli O157:H7 that occurred in the Pacific Northwest, illustrating the need for additional measures to detect, control and prevent foodborne pathogens. For many years leading up to 1993, the Agency was working on ways to control foodborne pathogens like E. coli O157:H7 and Salmonella. This work led to the development of the PR/HACCP regulations for FSIS-inspected meat and poultry processing establishments. The proposed rule was published in February 1995.
IPP can focus on assessing and verifying the establishment’s implementation of its food safety plan and scientific support for producing safe food.
The final rule revolutionized how FSIS carries out its regulatory mission, and it provided the infrastructure for establishments to be proactive and better prevent harmful pathogens and contaminants in their products. Previously, IPP approved certain establishments’ specific production decisions, part of a command-and-control approach. The final rule made clear the importance of the Agency’s role in the inspection process. Now, FSIS sets appropriate food safety standards and maintains inspection oversight to ensure those standards are met. IPP can focus on assessing and verifying the establishment’s implementation of its food safety plan and scientific support for producing safe food.
“Changing policy to move the burden of identifying and correcting food safety hazards to the establishment, that modernized inspection and has certainly moved the needle on food safety and public health in the right direction!” — Dr. John Linville, Director of the FSIS Policy Development Staff
Dr. John Linville is the Director of the Policy Development Staff (PDS) at the FSIS Office of Policy and Program Development (OPPD). PDS specialists develop the instructions to field inspection personnel necessary to implement Agency policy, including directives with HACCP verification procedures for inspectors. When the rule was implemented, Linville was a supervisory veterinary medical officer and inspector-in-charge at a poultry plant in Alabama. “HACCP has been a boon for inspection and has continued to improve food safety and public health. ‘Letting the system work,’ was a tough pill to swallow for those of us in the field when it was implemented. Twenty-five years later, it would be hard to imagine going back to the old way of doing inspection,” said Linville. “Changing policy to move the burden of identifying and correcting food safety hazards to the establishment, that modernized inspection and has certainly moved the needle on food safety and public health in the right direction!”
A major component of PR/HACCP final rule’s success has been its implementation of microbial testing programs. FSIS laboratory staff analyze hundreds of samples daily that are submitted by inspectors around the country.
Under the PR/HACCP rule, there arose a greater focus on harmful bacteria and other contaminants that are not visible to the naked eye and, therefore, undetected when primarily using sensory-focused inspection. The final rule overhauled the methods IPP used to carry out their inspection duties to verify that establishments have HACCP plans to prevent pathogenic microorganisms and bacteria present in meat and poultry products. A major component of PR/HACCP final rule’s success has been its implementation of microbial testing programs; the three FSIS Food Safety Laboratories are a crucial part of the FSIS inspection process. At the three FSIS laboratories in Athens, Georgia; St. Louis, Missouri; and Albany California, staff analyze hundreds of samples daily that are submitted by inspectors around the country.
FSIS microbiologists support the food safety mission by analyzing samples of products for presence of dangerous pathogens. Kay Williams is the Microbiology Branch Chief of the Eastern Laboratory in the Office of Public Health Science (OPHS). “Back in the 90s, to perform tests for a baseline study and culture the bacteria for Salmonella confirmation, we were receiving microbiology samples in large heavy boxes closed with straps and had to get them from the post office every day. We were receiving whole (40- to 60-pound) turkeys in huge sample boxes!”
After the implementation of the final rule, however, FSIS scientists began using newer technology. One was a biochemistry procedure to evaluate the presence of antigens or antibodies in a sample — enzyme-linked immunosorbent assay (ELISA). ELISA became much more commonly used in the food industry after 1996. HACCP has led to much innovation in the food-testing industry, thereby continually improving the technology available for scientists to use in their laboratory procedures, including FSIS.
“Before HACCP, the labs would gather and hold samples to start the analyses at the beginning of the week so there was no weekend work,” said Dr. William Shaw, Executive Associate for Laboratory Services in OPHS. “With HACCP they moved to a sample-by-sample analysis when received, which led microbiologists to work in the lab 7 days a week to provide results as soon as possible.” FSIS estimated that the rule would increase scientists’ total workload by 261 percent. This necessitated new hires in the laboratory, prompting the laboratories to hire local university and vocational school students for part-time work on the weekends and during the week.
Twenty-five years in, the PR/HACCP rule continues to evolve as does FSIS’ use of laboratories and science-based inspection.
Twenty-five years in, the PR/HACCP rule continues to evolve as does FSIS’ use of laboratories and science-based inspection. Additional industries have been, or will soon be, required to implement HACCP systems and have integrated the safety principles into their food production. Siluriformes (“catfish”) is now regulated under the Federal Meat Inspection Act and so subject to these requirements. Egg products are already on their way, with staggered effective dates. Most provisions were effective on Dec. 28, 2020. Other provisions related to Sanitation SOPs will be effective on Oct. 29, 2021, implementation of HACCP systems on Oct. 31, 2022, and plants that produce egg substitutes or freeze-dried egg products and imports of these products will be regulated by FSIS on Oct. 30, 2023.
These activities are evidence that, 25 years since its first requirement in the meat and poultry industries, HACCP remains an essential, relevant tool in ensuring effective, science-based food inspection.
In our next article, we will look more closely at how the rules and regulations for HACCP changed FSIS operations in the field and how inspection and food safety operations have continued to evolve.